1. The Role of Clinical Research in securing the Future of the Industry in Ireland – A Molecular Medicine Ireland perspective Ruth Barrington Chief Executive Molecular Medicine Ireland 1

2. Molecular Medicine Ireland (MMI) Vision - improved healthcare through the development of diagnostics and therapies from concept to realisation The mission of MMI is to mobilise the strengths of the five partner institutions and their associated hospitals to build a sustainable national system to coordinate, support and promote translational and clinical research

3. MMI Board – Academic/Industry Partnership Dr Damian O’Connell, Pfizer, Chair Dr Will Deare, AmGen Ms Helen Ryan, Creganna Dr Marina Zvartau-Hind, GSK Dr John Climax, ICON Mr Dave Shanahan, IDA Prof Larry Egan NUIG Secretary – John Coman, UCD Prof Bill Powderly, UCD Prof Des Fitzgerald, UCD Prof Dermot Kelleher, TCD Prof David Lloyd, TCD Prof Gerry McElvaney, RCSI Prof Hannah McGee, RCSI Prof Tim O’Brien, NUIG Prof Jonathan Hourihane, UCC

4. Why Pharma is important to Ireland Life science sector exports – €40bn+ 44,000 employed 8/10 top pharma companies Making people healthier –Public expenditure on pharmaceuticals = €2bn pa –70m prescribed drugs –GMS/CDS pa

5. Clinical Research – Why we need it to improve the quality of care for patients and the population, to enhance the reputation of clinical research in Ireland to facilitate innovation by indigenous companies to attract R&D investment by international pharma and medical device companies.

6. Clinical Research – why we need it Clinical trials are a necessary step in demonstrating the safety and effectiveness of new medicines, vaccines and devices or new applications for established products before they are used in the clinical care of patients

7. Clinical Trials – Economic return Clinical trials create employment –in the conduct of trials, –in the companies that use trials to test their products and –through the foreign direct investment attracted by clinical trial capacity

8. Clinical Trials – Economic Benefit The economic benefit in the US from eight clinical trials exceeded $15 bn over 10 years US National Institute of Neurological Disorders and Strokes

9. Clinical Research – Economic Return Wellcome Trust et al found that a £1 investment of public or charitable funds in cardiovascular disease research yielded a stream of benefits to the UK thereafter equivalent in value to earning £0.39 per year in perpetuity. Equivalent rate of return for investment in mental health research was £0.37 for every £1 invested in perpetuity.

10. Clinical Trials Capacity – a national priority? Ireland ‘a leading country for the timing, access and relevance of clinical trials’. Renewed Programme for Government

11. Clinical Trials Capacity – a national priority? ‘the development of a clinical trials research system is critical for the future growth and development of (the life science sector) in Ireland (both indigenous and MNCs) and to ensure that we leverage investments in research and development - translating from bench to bedside’. Report of the Innovation Taskforce

12. Clinical Trials Capacity – a national priority? Building clinical research capacity at the core of –the Health Research Action Plan (DOHC/DETI) –HRB Business Strategy

13. Contribution to National Recovery ‘Productive, high quality research, undertaken by highly skilled research teams working closely with industry partners will continue to be a core investment priority for Government.’ ‘Government will deliver the Health Information Bill which will speed up ethical review of health research trials and investigations.’ ‘Government will invest in R&D industry/third level sector collaboration.’ The National Recovery Plan 2011-14

14. Clinical Trial Activity in Ireland Applications of IMP Clinical Trials reviewed by the IMB

15. IMP STUDIES APPROVED BY IMB 2009

16. NUMBER OF APPLICATIONS & ON-GOING CTS IN NORDIC COUNTRIES & IRELAND Ref: Stinta Gestrelius, Nordic Co-operation in Clinical Research - Opportunities and Challenges (18 February 2009 & updated 30 March 2009)

17. MARKETING AUTHORISATION APPLICATIONS FOR CLINICAL TRIALS EMA 2009

18. COMMERICAL & NON-COMMERCIAL CTS APPLICATIONS

19. Key Metrics for Commercial Clinical Trials – Core Countries Start up speed – median number of days from receipt of protocol package to letter of regulatory approval/ethics approval. Cycle time – median number of days from regulatory approval to last patient’s first visit. Recruitment reliability – number of actual patients randomised as percentage of number planned per study.

20. Ireland not core for industry CTs From an industry perspective, clinical research in Ireland is –fragmented, –unpredictable, –overly dependent on personal connections, –has too many problems with regulatory compliance, –is expensive vis a vis the size of the market –is not conducted in a coordinated manner.

21. So what is being done to build capacity? MMI mission Irish Clinical Research Infrastructure Network – ICRIN HRB/Wellcome Trust Dublin Centre for Clinical Research ICORG, RCSI – CIST, C-STAR Academic Health Centres

22. ICRIN Vision Ireland is a country of choice for scientifically relevant multi-centre clinical studies and trials in specialist fields where partners are strong.

23. Irish Clinical Research Infrastructure Network - ICRIN HRB and HSE funded Coordinating facilities, expertise and processes to create a national system for clinical research –Research readiness, SOPs, ethics, IRNN Building capacity for clinical research – GCP, indemnity, sponsorship, Roadmap, EI Clinical Trials Liaison Services, therapeutic groups Integrating Irish network with the European Clinical Research Infrastructure Network (ECRIN)

24. ICRIN Working Group Composition Professor Larry Egan, NUI Galway, Chair Marie Mellody, ICRIN Coordinator CRC directors and investigators Clinical research personnel Terms of Reference to facilitate scientifically relevant investigator and industry led multi-centre clinical trials in the ICRIN network

25. What will the ICRIN network offer? CRCs in Dublin, Cork and Galway networked together operating to agreed standards to recruit patients to multi- centre studies –Acting as hubs for research activities in their hospitals –Each a gateway to network expertise & resources –Working to agreed list of research services & costs –Lead CRC coordinating ethical, regulatory & site specific approval, indemnity/sponsorship within agreed time limit –Supporting a web portal that offers up to date information on network services and expertise –Working with therapeutic groups to conduct multi- centre and multi-national studies

26. Dublin Centre for Clinical Research Clinical Research collaboration between MMI, RCSI, TCD and UCD Major Investment in clinical research infrastructure for Dublin: –New Clinical Research Facility for TCD in the heart of St. James’s Hospital –A network to conduct multi-centre studies and clinical trials –Enlargement and up-skilling of Research Nurse resources –IT infrastructure that supports multi-centred clinical research –Formation of Therapeutic and Clinical Interest Groups

27. Dublin Centre for Clinical Research - Achievements Therapeutic/Clinical Interest groups supported Diabetes, Respiratory, GI, Inflammatory Skin Disease, Neuropsychiatry, Michael Gill, Prostate Cancer,HIV/TB, Neurodegeneration, Ophthalmology Studies completed/underway – 10 at 6 hospitals Patients recruited – 2,185 patients recruited Nurse education – RCSI Cert.in Clinical Research Nursing Clinical informatics/ Study management – in place Standard form for ethical approval of non-IMP studies Clinical Trial – first CT has IMB and ethical approval

28. What’s missing? The Integrated Landscape HSE support for clinical research as a core function of the health service Financial support for therapeutic groups linked to health service priorities, academic excellence and industry needs Legislation to streamline ethical approval and sharing of patient information Sustainable funding for core CRC & network coordination costs Funding for academic clinical trials

29. What will an integrated landscape for clinical research give us? Start up speeds, cycle times and recruitment reliability that make Ireland a core country for industry-led scientifically-relevant, multi-centre clinical trials in specialist fields where the academic partners are strong.

30. Industry’s contribution to making Ireland core for clinical trials Continue to make the case for building the network, streamlining processes and health service commitment. Engage with ICRIN, DCCR, CRCs and therapeutic groups to plan and conduct multi- centre trials. An Irish Clinical Trials Initiative? –Public/industry partnership to make Ireland a core country for clinical trials. –French and Italian models

31. www.MolecularMedicineIreland.ie